MN MPJE 2020

Whenever an Rx drug containing an opiate is dispensed to a pt for outpt use, the pharmacy or practitioner dispensing the drug must prominently display on the label or container a notice that states _____.

"Caution: Opioid. Risk of overdose and addiction."

Txfer limitations for CIII-Vs

*Refer to DEA CS Manual*

Information required to be on an outpt Rx label

- *Name, address*, and telephone number of the *filling pharmacy* - Central service pharmacies shall use the name, address, and telephone number of the pharmacy dispensing the medication to the pt - Pt's name *(federal - if on Rx)* - *Rx number* - *Name of prescribing practitione* - SIG *(federal - if on Rx)* - Name of mfr/dstr of the finished dosage form of the drug - Auxiliary labels PRN *(federal - cautionary statements if on Rx)* - Date of original issue or renewal *(federal - or filling)* - Generic or trade name of drug and strength, except when specified by prescriber to the contrary - If combining premanufactured drug products, the names of the products, or a category of use name shall suffice - If cmpding basic pharmaceutical ingredients, the common pharmaceutical name, if such exists, the names and strengths of the principal active ingredients or a category of use name shall suffice

BOP Members

- 3 public members - 6 actively practicing MN pharmacists w/ at least 5 yrs consecutive practical experience immediately prior to appt

Removal of a high-alert drug from an ADC must be checked by a second licensed health care professional to ensure that the Rx drug order is being correctly interpreted and that the correct drug has been removed. This requirement does not apply when:

- A pharmacist has reviewed and approved the Rx drug order prior to the removal of the high-alert drug from the system - A licensed practitioner controls the ordering, preparation, and administration of the medication during a medical procedure - The prescribing practitioner has determined that the high-alert drug must be administered before the drug order can be reviewed by a pharmacist or a second licensed health care professional

PMP Permissible Users

- A prescriber or prescriber's agent to whom the prescriber is: - Prescribing or considering prescribing any CS - Providing emergency medical tx for which access to the data may be necessary - Providing care, and the prescriber has reason to believe, based on clinically valid indications, that the pt is potentially abusing a CS - Providing other medical tx for which access to the data may be necessary for a clinically valid purpose and the pt has consented to access to the submitted data - A dispenser or dispenser's agent to a pt whom that dispenser is dispensing or considering dispensing any CS - A licensed pharmacist who is providing pharmaceutical care for which access to the data may be necessary to the extent that the information relates specifically to a current patient for whom the pharmacist is providing pharmaceutical care: - If the pt has consented to access to the data - If the pharmacist is consulted by a prescriber who is requesting data - An individual who is the recipient of a CS Rx for which data was submitted, or a guardian of the individual, parent or guardian of a minor, or health care agent of the individual acting under a health care directive - Personnel or designees of a HRLB, or of the Emergency Medical Services Regulatory Board, assigned to conduct a bona fide investigation of a complaint received by that board that alleges that a specific licensee is impaired by use of a drug, has engaged in activity that would constitute a crime, or has obtained a CS from a prescriber in unusual amnts or presented a dispenser w/ a false Rx - Personnel of the board engaged in the collection, review, and analysis of CS Rx information - Authorized personnel of a vendor under contract with the state of MN who are engaged in the design, implementation, operation, and maintenance of the PMP as part of the assigned duties and responsibilities of their employment, provided that access to data is limited to the minimum amount necessary - Federal, state, and local law enforcement authorities acting pursuant to a valid search warrant - Personnel of the MN health care programs assigned to use the data collected under this section to identify and manage recipients whose usage of CSs may warrant restriction to a single PCP, oupt pharmacy, and hospital - Personnel of the DHS assigned to access the data - Personnel of the health professionals services program (pt must consent). The health professionals services program personnel shall not provide this data to a HRLB or the Emergency Medical Services Regulatory Board

Security requirements for drugs stored at a nursing station

- A well-illuminated, locked drug cabinet/room shall be equipped with clearly labeled cubicles to ensure physical separation of individual pt prescribed medications. Medications may be stored in secured individual pt storage areas or secured portable storage carts providing separate compartments for individual patients. - A container or compartment that is capable of securing CSs with a lock or other safeguard system shall be permanently attached to storage carts or medication rooms.

Rx drug orders that are entered into a computer system but never dispensed to the pt may be txferred to another pharmacy if all of the following conditions are met:

- All Rx drug order information has been entered into the computer system of the txferring pharmacy - The information is displayed on the pt's profile in a manner that indicates the Rx drug order was not filled at the transferring pharmacy - There is present, either in the computer system or on the hard copy Rx drug order, the unique identifier of the person who entered the Rx drug order information into the system and of the pharmacist who certified this entry, and of the pharmacist who performed the quality assurance verification. If the quality assurance verification has not occurred, then the Rx information exchanged must be from the original written Rx drug order - The original Rx drug order is kept on record according to MN Statutes, section 151.211

For which types of fills must a pharmacist initiate counseling?

- All new Rxs - RFs if deemed necessary by pharmacist's professional judgement Must be in-person whenever applicable Personal communication by the pharmacist is not required for inpts of a hospital or other institution where other licensed HCPs are authorized to administer the drugs, or where a pt or pt's agent or caregiver has expressed a desire not to receive the consultation. For mail/delivery, the consultation must still be provided but may be accomplished by phone/written materials.

Consultation Area Requirements for Community/Outpt Pharmacies

- Allows for consultation w/ a reasonable assurance of privacy - If partitions are used, they must be sound-dulling and at least 7' high and 24" deep. The pt must be able to enter the partitioned area so that the partitions are on each side of the pt. - Consultation areas w/out partitions may be approved if the board deems the consultation area will provide a reasonable assurance of privacy. - Must not contain any item for sale apart from the articles needed for counseling sessions. - Pharmacists must have access to pt profiles. - Must be accessible to the pt from the outside of the Rx dispensing area and be open at all times when the pharmacy is open. - A pharmacy licensed before January 1, 2011, must meet the standards within two years of that date, unless the pharmacy has an existing counseling area that has been deemed by the board to provide a reasonable assurance of privacy.

Beginning January 1, 2021, a prescriber or their agent must access the PMP in what instances? When do these guidelines not apply?

- Before the prescriber issues an initial Rx order for a CII-IV opiate to the pt - At least once Q3M for pts receiving an opiate for tx of chronic pain or participating in medically assisted treatment for an opioid addiction Does not apply if: - Pt is receiving palliative/hospice/EOL care - Pt is being treated for pain due to ca or the tx of ca - DS is 5 days or less w/ no RFs - Prescriber and pt have a current or ongoing provider/patient relationship of a duration > 1 yr - Rx order is issued w/in 14 days (surgery) or 3 days (oral surgery) or follows the prescribing protocols established under the opioid prescribing improvement program - CS is prescribed or administered to an inpt - CS is lawfully administered by injection, ingestion, or any other means to the pt by the prescriber, a pharmacist, or by the pt at the direction of a prescriber and in the presence of the prescriber or pharmacist - Due to a medical emergency, it is not possible for the prescriber to review the data before the prescriber issues the Rx order for the pt - Technological failure of the PMP (prescriber must report this to the board)

An Rx drug order for the following drugs is not valid, unless it can be established that the Rx drug order was based on a documented pt evaluation, including an examination, adequate to establish a dx and identify underlying conditions and CIs to tx:

- CSs - Muscle relaxants - Centrally acting analgesics w/ opioid activity - Drugs containing butalbital - PDE-5Is for ED

Pharmacies accessing a common electronic file or database used to maintain required dispensing information are not required to txfer Rx drug orders or information for dispensing purposes between or among pharmacies participating in the same common Rx file or database; provided, however:

- Common file or database must contain complete records of each Rx drug order and RF dispensed - A hard copy record of each Rx drug order txferred or accessed for purposes of RFing must be generated and maintained at the pharmacy RFing the Rx or to which the Rx has been txferred

What information must be recorded for prepackaged medications?

- Date - Identification of drug - Name - Dosage form - Mfr/dstr - Lot number assigned by mfr/dstr - Strength - Exp date assigned by mfr/dstr (if any) - Container specification - Copy of the label - Unique identifier of the packager - Unique identifier of the supervising pharmacist - Qty per container - Internal control number or date

Additional labeling requirements for outpt IV admixtures

- Date of cmpding - BUD - Storage requirements (if other than RT) - Infusion/administration rate - Administration times, frequency, or both - Other accessory cautionary information which in the professional judgment of the pharmacist is necessary or desirable for proper use by and safety of the pt

What information must a contract pharmacy provide when delivering medications to a contract pharmacist to be dispensed at a LTCF?

- Drug name - Drug strength - Mfr - Mfr lot number - Mfr exp date - Date drug dispensed

At a minimum, what 5 items are required for assessment of an ADC? How often must these items be assessed? Do all 5 items need to be assessed at the same time?

- Drugs are properly stored in their assigned locations and in pharmacy-approved configurations - Outdated drugs are removed and replaced - Only approved drugs are in the device - Inventory levels are appropriate based on usage - The device and drugs are secure At least monthly No

Allowed technician:pharmacist ratios

- General - 2:1 - IV admixture preparation, setting up or preparing pt-specific Rxs in unit-dose or modified unit-dose pkging, prepackaging (part 6800.3200), and cmpding - 3:1 May exceed by 1 if at least 1 technician is certified A PIC may petition to supervise > 3 technicians at a time - must submit plan for maintenance of pt safety; Assume request approved if no denial w/in 90 days Clerical personnel and interns submitting hours toward completion of the 1,600-hour requirement NOT included in these ratios

In order for a pt to access an investigational drug, biological product, or device, a physician must document in writing that the pt:

- Has a terminal illness - Has, in consultation with a physician, considered all other tx options currently approved by the FDA - Has been given an Rx or recommendation by a physician for an investigational drug, biological product, or device - Has given informed consent, in writing, for the use of the investigational drug, biological product, or device - If the pt is < 18 YO, or lacks the mental capacity to provide informed consent, a parent or legal guardian has given informed consent, in writing, on behalf of the pt

Labeling requirements for drugs prepackaged for emergency use

- ID of pharmacy or other source - Name of drug or list of ingredients - Strength of drug or amount of ingredients - Auxiliary labels PRN - Exp date, if any - Usual dose - Control number or date of issue

At a minimum, an ADC must maintain records of:

- Identity of all personnel who access the automated unit, including witnesses - Reason for access - Date and time of access - Name, strength, dosage form, and quantity of the drug removed, returned, or wasted - Name of the pt for whom the drug was ordered; - Any additional information the PIC may deem necessary PIC must review and deal w/ discrepancies on a regular basis

Pharmacy Technician Education and Training Requirements

- Initial - High School education or equivalent - Renewal - Board-approved technician training program (through vocational/technical college/institution, national pharmacy organization, USPHS, or employer) - Employer-based programs must offer at least 24o hrs in a 1 yr period Any individual whose registration lapses for a period of > 1 yr must meet the registration requirements in effect at the time the individual applies for reinstatement of registration.

A written Rx or an oral Rx reduced to writing, when issued for a CII-V, is void unless it:

- Is written in ink - Contains the name and address of the person for whose use it is intended - States the amnt of the CS to be cmpded or dispensed - States SIG - Contains, for written Rxs: - Address of prescriber - Federal registry number of prescriber - Designation of prescriber's branch of healing arts - Contains, for oral Rxs: - Name of prescriber - Address of prescriber - Designation of prescriber's branch of healing arts - Shows the date when signed by the prescriber (written), or the date of acceptance in the pharmacy (oral)

A drug shall be deemed to be adulterated if:

- It consists in whole or in part of any filthy, putrid or decomposed substance - It has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been rendered injurious to health, or whereby it may have been contaminated with filth - The methods used in, or the facilities or controls used for, its mfr, processing, packing, or holding do not conform to or are not operated or administered in conformity with cGMP to assure that such drug is safe and has the identity, strength, quality, and purity characteristics, which it purports or is represented to possess - The facility in which it was produced was not registered by the FDA or licensed by the board - Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health - It bears or contains, for purposes of coloring only, a color additive which is unsafe - It purports to be or is represented as a drug the name of which is recognized in the USP-NF, and its strength differs from, or its quality or purity falls below, the standard set forth therein - Determination of strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act - Strength differs from, or its purity or quality differs from that which it purports or is represented to possess (unless contained in USP-NF and plainly stated on label) - Any substance has been mixed or packed therewith so as to reduce its quality or strength, or substituted wholly or in part therefor

A drug shall be deemed to be misbranded if:

- Its labeling is false or misleading in any way - In pkg form and not dispensed pursuant to an Rx unless it bears a label containing: - The name and place of business of the mfr, packer, or dstr - A statement of ingredients - An accurate statement of the net qty of the contents in terms of wt, measure, or numerical count, provided, however, that reasonable variations shall be permitted, and exceptions as to small pkgs shall be allowed in accordance with the federal act - Any word, statement, or other required information is not prominently placed on the label - Must be able to be read and understood by the ordinary individual under customary conditions of purchase and use - It otherwise fails to meet the labeling requirements of the federal act

A material, cmpd, mixture, or preparation that contains any qty of ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine, may be dispensed only upon the prescription of a duly licensed practitioner authorized by the laws of the state to prescribe prescription drugs, except when the drug product:

- May be lawfully sold OTC under the FDCA - Is labeled and marketed in a manner consistent w/ the pertinent OTC Tentative Final or Final Monograph - Is mfr'd and dstr'd for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse - Is not marketed, advertised, or labeled for the indication of stimulation, mental alertness, wt loss, muscle enhancement, appetite control, or nrg - Is in solid PO dosage forms, including guaifenesin 400 mg/ephedrine 25 mg soft gelatin caplets according to label instructions - Is an anorectal preparation containing not > 5% ephedrine - Is sold in a manner that does not conflict w/ regulation of sale of methamphetamine precursors (see separate flash card) - Contains ephedra or ma huang and lawfully marketed as a dietary supplement under federal law

Required References

- Most recent editions of the laws relating to the practice of pharmacy - Rules of the BOP - Current copy of the DEA regulations - Current copy of the CFR, title 21, parts 1300-1316 - At least one current reference from each of the categories in items A to C (Pharmacotherapy, Dosage and Toxicology, General References) - At least one dosage and toxicology reference must be in hard copy form that is appropriate to the majority of the patient base of the pharmacy. - LTC pharmacies: Most recent edition of MN DoH rules pertaining to medication handling in LTCFs and a current general reference on geriatric pharmacotherapy (in addition to above) - Specialty pharmacies serving a unique population must have a current general reference appropriate to the patient base served (in addition to above) Unless specified, may be electronic or hard copy form

Requirements of buyer for OTC methamphetamine precursor sales

- Must be 18 YO - Must show valid photo ID showing DOB - Must sign paper/electronic log detailing date of sale, name of buyer, and amnt sold Rx not required

Minimum Requirements for Use of Electronic Data Processing Equipment When Used to Store Rx Information

- Must be structured so that no intervening person having access to pt Rx information when sending Rxs electronically - Must not infringe on a pt's freedom of choice of pharmacy provider - Must guarantee the confidentiality of the information contained in the system's storage devices and databases - Must be capable of producing a hard copy daily summary of CS transactions and be capable of producing a hard copy printout of legend drug transactions going back 2 yrs - Must be capable of recording and carrying in the record all dates of RFs of any Rx drug order and the unique identifier of the pharmacist - Must be capable of producing a pt profile indicating all drugs being taken and the dates and qty's of fills or RFs of Rx drug orders dispensed for the pt and: - Data shall be kept in the computer system and be immediately retrievable x at least 2 yrs (hard copy okay for hospital or LTC inpts) - Must be capable of being reconstructed in the event of a computer malfunction or accident resulting in destruction of the system's storage devices or databases - Must be capable of producing a printout providing a RF-by-RF audit trail for any specified strength and dosage form of any CS. The audit trail must include: - Name of prescribing practitioner - Name of pt - Location of pt - Qty dispensed on each RF - Date of dispensing of each RF - Name or unique identifier of the dispensing pharmacist - Rx number - Must be capable of identifying any authorized changes in drug, qty, or SIG of any Rx drug order including the date of change, the identity/unique identifier of the individual making the change, and what the original information was - Alternatively, a new Rx drug order may be created for each authorized change - Must be capable of preventing unauthorized access, modification, or manipulation of pt Rx data

DS limits for emergency Rxs

- Must not exceed a 30 DS, or the quantity originally prescribed, whichever is less - If the std unit of dispensing for the drug is > 30 DS, the amnt of the drug dispensed or sold must not exceed the std unit of dispensing - Exception: CSs for szs - 72 hr supply MAX

Requirements for physicians to dispense drugs

- Must obtain license from BOP, may renew annually - Limited to dispensing drugs in a limited service pharmacy and shall be governed by the rules adopted by the BOP - Pharmaceutical care is not reasonably available if the limited service pharmacy in which the physician is dispensing drugs is located in a health professional shortage area, and no other licensed pharmacy is located within 15 miles of the limited service pharmacy - Must certify each Rx as a pharmacist would - May supervise a certified pharmacy technician - Physician does not need to be physically present, but physician or a pharmacist must at least be available electronically or by phone

Pt Medication Profiles - A reasonable effort must be made by the pharmacy to obtain, record, and maintain at least the following information regarding individuals obtaining Rx services at the pharmacy:

- Name - Address - Telephone number - DOB or age - Gender - Significant PMH - Dx state(s) - Known allergies and drug reactions - Comprehensive list of medications and relevant devices being used showing the Rx number - Name and strength of the drug or device - Qty and date received by the pt - Name of the prescriber * If this information is obtained by someone other than the pharmacist, the pharmacist must review the information with the pt - Pharmacist comments relevant to the individual's drug therapy, including, where appropriate, documentation of the following for each prescription: - Pharmaceutical care needs of the pt - Services rendered by the pharmacist - Pharmacist's impression of the pt's drug therapy This documentation is NOT required for residents of a licensed nursing home where a consultant pharmacist is performing regular drug regimen reviews.

Labeling requirements for unit-dose medications from the mfr

- Name of drug - Dosage form - Strength - Mfr name - Lot number - Expiration date

What information must be on the labeling of a prepackaged medication?

- Name of drug - Strength - Name of mfr/dstr of the finished dosage form - BUD not > 1 yr from prepackaging date or time to mfr exp date (whichever is earlier), or any earlier date which, in the pharmacist's professional judgment, is preferable - Internal control number or date - Physical description, including any ID code that may appear on tablets and capsules or a bar code based on the NDC. - Does not need to be placed on individual unit-doses, provided that the pharmacy dispenses the unit-doses in outer packaging that contains a physical description of the drug or the pharmacy dispenses < a 72-hr supply of the unit-doses

When an additional drug is added to intravenous admixtures, the admixtures shall be labeled on the original label or with a distinctive supplementary label indicating the:

- Name of drug added - Amnt of drug added - Date of addition - Time of addition - Expiration - Unique identifier of the person adding the drug

Labeling requirements for the sale of non-intoxicating cannabinoids extracted from hemp other than food that is intended for human or animal consumption

- Name of mfr - Location of mfr - Phone number of mfr - Website of mfr - Name of testing lab - Address of testing lab - An accurate statement of the amnt or % of cannabinoids found in each unit of the product meant to be consumed - A statement stating that this product does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the FDA unless the product has been so approved

What information must dispensers submit to the board to comply w/ the PMP? For which Rxs are dispensers NOT required to report this information?

- Name of prescriber - Prescriber's NPI - Name of dispenser - Dispenser's NPI - Rx number - Pt name -Pt address - Pt DOB - Date written - Date filled - Name of CS - Strength of CS - Qty prescribed - Qty dispensed - DS NOT required if: - For individual residing in a nursing home, boarding care home, or sex offender program facility and distributed through automated drug distribution system - Samples Dispenser must supply user w/ conspicuous notice of information being reported

Labeling requirements for drugs dispensed to inpts on the basis of chart orders

- Name of pt - Name of drug - ROA of drug when necessary for clarification - Strength of drug - Auxiliary labels PRN - Exp date, if applicable - Date dispensed

The label for a filled veterinary Rx that is dispensed by a licensed pharmacy must include:

- Name of the client or animal (non food-producing) - Name of the owner and the specific name and address of the facility at which the filled Rx will be used (food-producing) - Species - Name of drug, except when specified by the prescriber to the contrary - Strength of drug, except when specified by the prescriber to the contrary - Qty of drug, except when specified by the prescriber to the contrary - In the case of combining premanufactured drug products, the names of the products, or category of use may suffice - Name of the mfr/dstr of the finished dosage form - Date of issue - Directions for use - Withdrawal time (food-producing only) - Cautionary statements PRN - Name of pharmacy - Address of pharmacy - Telephone number of pharmacy - Central service pharmacies must use the name, address, and telephone number of the pharmacy DISPENSING the medication to the client; - Name of prescribing veterinarian - Address of prescribing veterinarian (food-producing only) - Rx number When the veterinary drug is in the mfr's original package and the information that is required on the label includes the drug or drugs, strength of the drug or drugs, directions for use, withdrawal time for food-producing animals, and cautionary statements, a label will be required on each individual bottle or package.

Except for radiopharmaceuticals, all drugs dispensed to or for a pt, other than an inpatient of a hospital must be labeled with the following information:

- Name of the pharmacy filling the Rx drug order - Address of the pharmacy filling the Rx drug order - Telephone number of the pharmacy filling the Rx drug order - Central service pharmacies shall use the name, address, and telephone number of the pharmacy DISPENSING the medication to the pt - Pt's name - Rx number - Name of prescribing practitioner - Directions for use - Name of mfr/dstr of the finished dosage form - Auxiliary labels PRN - Date of original issue or renewal - Generic or trade name of drug except when specified by prescriber to the contrary - Strength of drug, except when specified by prescriber to the contrary - In the case of combining pre manufactured drug products, the names of the products, or a category of use name shall suffice. - In the case of cmpding basic pharmaceutical ingredients, the common pharmaceutical name, if such exists, the names and strengths of the principal active ingredients or a category of use name shall suffice - Rx drug orders filled as part of a central service operation must bear an identifier that indicates the central service pharmacy at which they were filled - Any dispensed legend drug, or non legend drug not dispensed in the manufacturer's original container, must be labeled with its physical description, including any ID code that may appear on tablets and capsules. Does not apply to drugs dispensed as part of an investigational drug study.

A written protocol w/ a physician, PA authorized to prescribe, or APRN authorized to prescribe must exist for the administration of vaccines by a pharmacist and must include, at a minimum:

- Name, dose, and route of each vaccine that may be given - Pt population for whom the vaccine may be given - CIs and precautions to the vaccine - Procedure for handling an adverse reaction - Name, signature, and address of the physician/PA/APRN - Telephone number at which the physician/PA/APRN can be contacted - Date and time period for which the protocol is valid The pharmacist must: - Have successfully completed a program approved by the ACPE specifically for the administration of immunizations or a program approved by the board - Utilize the MN Immunization Information Connection (MIIC) to assess the immunization status of individuals prior to the administration of vaccines, except when administering influenza vaccines to individuals age 9 and older - Report the administration of the immunization to the MN Immunization Information Connection - Comply w/ guidelines for vaccines and immunizations established by the ACIP - Do not need to comply when administering a vaccine pursuant to a valid, pt-specific order issued by a physician/PA authorized to prescribe/APRN authorized to prescribe provided that the order is consistent with the FDA-approved labeling of the vaccine (must still have and follow protocol, other than immunization schedule)

Rx RF limits

- Non-controlled and CV: RFs allowed up to 12 months after issue date - CII: No RFs allowed - CIII-IV: No > 5 RFs up to 6 months after issue date

CE Advisory Task Force Members

- Not > 10 members - 3 members shall be pharmacists designated by the Minnesota State Pharmaceutical Association - 3 members shall be pharmacists designated by the Minnesota Society of Hospital Pharmacists - 2 members shall be pharmacists designated by the College of Pharmacy of the University of Minnesota - 2 members shall be designated by the board Shall meet at least quarterly and shall annually elect a chair and vice chair from its membership. The executive director of the BOP shall act as secretary.

Required Equipment for Cmpding

- One Rx balance, Class A as defined in USP-NF, with one set of accurate metric weights from 50 mg-100 g, or an electronic balance of equal or greater accuracy - Measuring devices capable of accurately measuring volumes from 1 mL to at least 500 mL - Mortars, pestles, spatulas, funnels, stirring rods, and heating apparatus as necessary to meet the needs of that pharmacy - Other equipment as necessary to comply with the requirements of USP <795> - A refrigerator used only for drug storage or a separate compartment used only for drug storage within a general use refrigerator - Manual, electromechanical, or electronic temperature recording equipment, devices, or logs shall be used to document proper storage of legend drugs every business day - A sink with hot and cold running water -A toilet with a hand-washing lavatory and disposable towels in a location that is reasonably accessible. - Pharmacies preparing compounded sterile products are required, in addition to above, to have: -Minimum equipment to comply with the USP <797> appropriate to risk-level requirements -Current reference materials/books for sterile products/IV incompatibilities -A current copy of USP <797> Must be clean and in good working order

What types of products do OTC methamphetamine precursor limits NOT apply to?

- Pediatric products labeled pursuant to federal regulation primarily intended for administration to children < 12 YO according to label instructions - Methamphetamine precursor drugs that are certified by the BOP as being mfr'd in a manner that prevents the drug from being used to mfr methamphetamine - Methamphetamine precursor drugs in gel capsule or liquid form Cmpds, mixtures, or preparations in pwd form where PSE constitutes < 1% of its total wt and is not its sole AI

Pt care guidelines for parenteral/enteral home healthcare

- Pharmacist must conduct and document pt training - Pharmacist shall monitor lab values for response to therapy and report any unexpected/untoward results to the responsible prescriber

Who has prescribing authority in MN? Are there

- Physicians - Dentists - Veterinarians - Podiatrists - APRNs - PAs (under a physician) - Optometrists (CS limited to CIV and CV) - Dental Therapists (under a dentist)

Return and reuse of drugs and devices

- Prohibited from accepting from pts or their agents for reuse, reissue, or resale any drugs, prescribed medications, chemicals, poisons, or medical devices - Exception: drugs in a hospital for inpt use only that have not left the span of ctrl of the pharmacy - Drugs from nursing homes and assisted living facilities may be returned to the dispensing pharmacy if: - Consultant pharmacist can assure proper storage conditions for the drugs in the facility and the drugs are stored in a secure area - The facility has 24-hr, on-site licensed nursing coverage 7 days/wk - The drugs are returned to the same pharmacy which dispensed the drugs - The integrity of such packaging remains intact (no reconstituted drugs, drugs requiring refrigeration, or controlled substances may be so returned) - The drugs are received by the pharmacy in the original mfr's packaging or pharmacist packager's unit-dose, unit-of-use, or strip packaging with each tablet or capsule individually wrapped and labeled, or in blister cards, which indicate the drug name and strength, the packager's name, and the manufacturer's or packager's lot or batch number. Drugs packaged by a pharmacy may be returned only if the pharmacy can demonstrate to the board that its packaging material and procedures will provide a package that will meet or exceed the criteria for class B packaging established by the USP, and that procedures have been developed and implemented to prevent the commingling of dosage units of different lot numbers or BUDs. - Pharmacies may accept returns of and redispense unopened, unused drugs in board-approved unit dose packaging and medical devices from county jails and juvenile correctional facilities - Must have a correctional employee trained in the delivery and storage of medications on hand 24/7, and the medication must be stored in a secured locked storage locker.

In cases where the physical characteristics of the immediate container of the medication do not permit full labeling, a partial label containing, at a minimum:

- Pt name - Rx number May be placed on the container and the complete labeling applied to an appropriate outer container.

Required Rx components for legend medical gases

- Pt's name - Pt's address - Date - Name of legend medical gas distributed - Qty of legend medical gas distributed - Name of prescriber - Address of prescriber All Rx and RF records must be maintained x at least 2 yrs

Additional labeling requirements for LTCF Rxs

- Qty of drug dispensed - Date of original issue, or in the case of a RF, the most recent date -Expiration date of all time dated drugs

What things must the PIC do when closing a pharmacy?

- Return the pharmacy license to the board office, noting the closing date - Notify the board as to the disposition of the Rx files, legend drugs, insulin, hypodermic syringes and needles, contraceptive drugs and devices, chemicals, and OTC drugs -If the pharmacy that is closing has been computerized, give a printout of all pt profiles to the pharmacy that is receiving the Rx files -Ensure all legend drugs are removed from the pharmacy at the time of closing and stored in a licensed pharmacy (must not be stored elsewhere, including in the custody of a pharmacist) - Inform the succeeding business occupying the premises and the landlord, if any, that it is unlawful to use the words "drugs," "drug store," or "pharmacy," or similar words in connection with the place of business unless it is a licensed pharmacy - Take a CS inventory - Shall serve as the final inventory of the closing pharmacy and the initial inventory of the pharmacy receiving the CS drugs - A copy of the inventory shall be included in the records of both pharmacies. It is not necessary to file a copy of the inventory with the DEA unless requested by the regional administrator. - If CS drugs are to be destroyed, the PIC must contact the DEA for instructions. - If CIII-Vs are being txferred, they shall be txferred on duplicate invoices, with each pharmacy keeping a copy. - If CIINs are being txferred, the transferee must submit a new DEA 222 Form to the transferor. - If the DEA does not approve of the txfer, instructions must be given to the pharmacy that is closing to dispose of the drugs according to the written instructions provided by the regional director. - Notify the public - A notice that informs pts that the pharmacy will close on a specified date and that gives the name, address, and telephone number of the pharmacy to which Rx files will be transferred must be distributed by publication of the notice in a local newspaper x 1 week prior to the closing date, a direct mailing to pts who have had at least one Rx filled at that pharmacy during the 6 months preceding the date of closing (should reach patients no later than one business day prior to the closing), and/or distribution of the notice to patients who are picking up Rxs at least 30 days prior to the closing date - For residents of LTCFs, the pharmacy shall provide a written notice to the pts, the caregivers of the pts, or the LTCFs in which the pts reside at least 30 days prior to the closing date

What course of action should a pharmacist take if a prescriber does not specify DAW on an Rx?

- Substitute w/ cheaper generic if one is available - Orange book consultation not required, can be up to pharmacist's professional judgement - Substitution not required if drug will not be covered by insurance - Substitute w/ cheaper biological product if one is available - Must consult purple book - Purchaser must be notified of substitution and may object

A pharmacist working w/in a pharmacy licensed by the board in the veterinary pharmacy license category may cmpd and provide a drug product to a veterinarian without first receiving a pt-specific Rx only when:

- The cmpded drug product is needed to treat animals in urgent or emergency situations, meaning where the health of an animal is threatened, or where suffering or death of an animal is likely to result from failure to immediately treat - Timely access to a cmpding pharmacy is not available, as determined by the prescribing veterinarian - There is no commercially mfr'd drug, approved by the FDA, that is suitable for treating the animal, or there is a documented shortage of such drug - The cmpded drug is to be administered by a veterinarian or a bona fide employee of the veterinarian, or dispensed to a client of a veterinarian in an amount not to exceed what is necessary to treat an animal for a period of 10 days - The pharmacy has selected the sterile or nonsterile cmpding license category, in addition to the veterinary pharmacy licensing category - The pharmacy is appropriately registered by the DEA when providing cmpded products that contain CSs

The following conditions must be met for a contract pharmacy to repackage medications from a bulk Rx container from an original dispensing pharmacy for a LTCF resident:

- The drug is dispensed by the original dispensing pharmacy according to a current, valid Rx - The original bulk Rx container for the resident is delivered by the original dispensing pharmacy directly to the contract pharmacist or pharmacy - The contract pharmacist or pharmacy verifies the name and strength of the drug, the name of the mfr of the drug, the mfr's lot or ctrl number, the mfr's exp date for the drug, and the date the drug was dispensed by the original dispensing pharmacy - The contract pharmacist or pharmacy verifies the validity and accuracy of the current Rx order - The contract pharmacist or pharmacy repackages the drug in board-approved unit-dose packaging, with labeling that complies with Minnesota Rules, part 6800.6300, and that identifies that the drug has been repackaged according to this section - The resident for whom the medication is repackaged obtains medications from or receives medications at a discounted rate from the original dispensing pharmacy under the resident's state or federal health assistance program or a private health insurance plan - The resident for whom the medication is to be repackaged, or the resident's authorized representative, has signed an informed consent form provided by the facility which includes an explanation of the repackaging process and which notifies the resident of the immunities from liability provided in this section

The board shall not issue an initial or renewed license for a pharmacy located outside of the state unless the applicant discloses and certifies:

- The location, names, and titles of all principal corporate officers and all pharmacists who are involved in dispensing drugs to residents of this state - That it maintains its records of drugs dispensed to residents of this state so that the records are readily retrievable from the records of other drugs dispensed - That it agrees to cooperate with, and provide information to, the board concerning matters related to dispensing drugs to residents of this state - That, during its regular hours of operation, but no < 6 days/wk, for a minimum of 40 hrs/wk, a toll-free telephone service is provided to facilitate communication between pts in this state and a pharmacist at the pharmacy who has access to the pts' records; the toll-free number must be disclosed on the label affixed to each container of drugs dispensed - That, upon request of a resident of a LTCF located in this state, the resident's authorized representative, or a contract pharmacy or licensed health care facility acting on behalf of the resident, the pharmacy will dispense medications prescribed for the resident in unit-dose packaging or, alternatively, comply with section 151.415, subdivision 5.

Any person, firm, or hospital cmpding, mixing, deriving, repackaging, or otherwise preparing a radioactive drug shall be licensed as a mfr, unless the drug is prepared for use by:

- The medical facility to which the facility preparing the product is physically attached - An individual pt when the drug is being dispensed on the order of a licensed practitioner

No licensed pharmacist shall participate in any arrangement or agreement whereby Rx drug orders or filled Rxs may be left at, picked up from, accepted by, or delivered to any place of business not licensed as a pharmacy except:

- The office or home of the prescriber - The residence of the pt - The hospital or LTCF in which a pt is confined - A pharmacy may deliver filled Rxs at the place of employment of the pt or a designated caregiver of the pt only if the pharmacy: - Obtains and documents the authorization of the pt or pt's caregiver for delivery at the place of employment - Ensures the filled Rx order is delivered directly to the pt or the pt's caregiver as authorized - Ensures the security of PHI

A pharmacist, when that pharmacist is not present within a licensed pharmacy, may access a pharmacy Rx processing system through secure and encrypted electronic means in order to process an emergency Rxs only if:

- The pharmacy from which the Rx drug order will be dispensed is closed for business - The pharmacist has been designated to be on call for the licensed pharmacy that will fill the Rx drug order - The Rx drug order is for a pt of a LTCF or a county correctional facility - The Rx drug order is not being processed through an automatic drug distribution system - The pharmacy from which the Rx drug order will be dispensed has relevant and appropriate policies and procedures in place and makes them available to the board upon request

A person having custody of or access to Rx orders shall not divulge the contents thereof or provide a copy thereof to anyone except to:

- The pt for whom the Rx was issued, the pt's agent, or another pharmacist acting on behalf of the pt or the pt's agent - The licensed practitioner who issued the Rx - The licensed practitioner who is then treating the pt - A member, inspector, or investigator of the board or any federal, state, county, or municipal officer whose duty it is to enforce the laws of this state or the US relating to drugs and who is engaged in a specific investigation involving a designated person or drug - An agency of govt charged with the responsibility of providing medical care for the pt - An insurance carrier or attorney on receipt of written authorization signed by the pt or the pt's legal representative, authorizing the release of such information - Any person duly authorized by a court order Such copies furnished shall bear on the face thereof the statement "Copy for information only," and may be filed to account for the dispensing of a drug only if such dispensing is authorized in writing or orally by the prescriber and communicated to the pharmacist dispensing and filing such copy

A pharmacist may, using sound professional judgment and in accordance with accepted standards of practice, dispense a legend drug w/out a current Rx drug order from a licensed practitioner if all of the following conditions are met:

- The pt has been compliant w/ taking the medication and has consistently had the drug filled or RF'd - The pharmacy from which the legend drug is dispensed has a record of an Rx drug order for the drug in the name of the pt who is requesting it, but the Rx drug order does not provide for a RF or the time during which the RFs were valid has elapsed - The pharmacist has tried but is unable to contact the practitioner who issued the Rx drug order, or another practitioner responsible for the pt's care, to obtain authorization to RF the Rx - The drug is essential to sustain the life of the patient or to continue therapy for a chronic condition - Failure to dispense the drug to the patient would result in harm to the health of the pt - The drug is not a CS, except for a CS that has been specifically prescribed to treat a sz disorder, in which case the pharmacist may dispense up to a 72-hr supply

When is an employer not mandated to report drug diversion of an employee regulated by a HRLB?

- The regulated person is self-employed - The knowledge was obtained in the course of a professional-pt relationship and the regulated person is the pt - Knowledge of the diversion first becomes known to the employer, health care institution, or other organization, either from: - An individual who is serving as a work site monitor approved by the health professionals services program for the regulated person who has self-reported to the health professionals services program, and who has returned to work pursuant to a health professionals services program participation agreement and monitoring plan - The regulated person who has self-reported to the health professionals services program and who has returned to work pursuant to the health professionals services program participation agreement and monitoring plan

Criteria for issuance of medications for residents of a LTCF going on leave from the facility

- Up to a 72-hr supply of medications in paper envelopes or other more suitable containers for use by a resident temporarily leaving the facility at times when the resident's pharmacy is closed or cannot supply the needed medication in a timely manner is allowed - A container may hold only 1 medication - Label on the container shall include: - Date - Resident's name - Facility - Name of the medication - Strength of medication - Dose - Time of administration - Initials of the person preparing the medication and label

IM and SC administration of drugs used to treat mental illnesses is permitted under the following conditions:

- Upon the order of a prescriber and the prescriber is notified after administration is complete - Pursuant to a protocol or collaborative practice agreement, and participation in the initiation, mgmt, modification, administration, and D/Cation of drug therapy is according to the protocol or collaborative practice agreement between the pharmacist and a licensed practitioner who would be able to prescribe the drug in question within their scope of practice (e.g. physician, APRN) Would not be appropriate to have this protocol dentist, optometrist, podiatrist, or veterinarian

What information may be added/changed on CS Rxs?

- Upon verification w/ pt, may add or change: - Pt's address - Upon consultation w/ prescribing practitioner, may add or change: - Dosage form - Drug strength - Drug quantity - SIG - Issue date - Such consultations and corresponding changes should be noted by the pharmacist on the Rx - Upon determining the Rx is legally valid, may add: - DEA number of prescriber - Never permitted to make changes to: - Pt's name - CS prescribed (except for generic substitution permitted by state law) - Prescribers signature

Admission in the health professional services program shall be denied to persons:

- Who have diverted CSs for reasons other than self-administration - Who have been terminated from this or any other state professional services program for noncompliance in the program - Currently under a board disciplinary order or corrective action agreement, unless referred by a board - Accused of sexual misconduct - Whose continued practice would create a serious risk of harm to the public

Duties of txferring pharmacist/intern

- Write the word "VOID" across the face of the current Rx drug order to make it invalid (written) or void all remaining RFs previously authorized and carried in the electronic record (electronic) - Record on the reverse side of the invalidated Rx drug order or in the electronically maintained record of the Rx drug order the name, address, telephone number, DEA number (if CIII-V) of the receiving pharmacy and the name of the receiving pharmacist or intern - Record the date of the txfer * Recording of Rx drug order txfers by cancellation of the electronic version of the Rx drug order is acceptable only when the quality assurance check has been completed.

Duties of receiving pharmacist/intern during a txfer

- Write the word "transfer," "copy," or a word of similar import on the face of the txferred Rx, and must obtain from the txferring pharmacist or intern all information required by law to be on an Rx, plus: - Date of issuance and of filling of the original Rx - Original number of RFs authorized - Number of valid RFs remaining - Date of last RF from original Rx - Original Rx number from which the Rx information was transferred - Txferring pharmacy's name, address, telephone number, DEA number (if CIII-V), and the name of the transferring pharmacist or intern

Dispensing Counter Requirements

-Must be at least 18" deep and provide 2 linear ft -Must be kept clear and free of all merchandise and other materials not currently in use in the practice of cmpding and dispensing, for each pharmacist and each technician working concurrently on cpmding and dispensing -Shall provide an additional space for computers if used in the dispensing process - Maintains an aisle behind the counter at least 36" wide, extending the full length of the counter, which shall be kept free of obstruction at all times

A pharmacist, when that pharmacist is not present within a licensed pharmacy, may accept a written, verbal, or electronic Rx drug order from a practitioner only if:

-The Rx drug order is for an emergency situation where waiting for the pharmacist to travel to a licensed pharmacy to accept the Rx drug order would likely cause the pt to experience significant physical harm or discomfort - The pharmacy from which the Rx drug order will be dispensed is closed for business - The pharmacist has been designated to be on call for the licensed pharmacy that will fill the Rx drug order; - Electronic Rx drug orders are received through secure and encrypted electronic means - The pharmacist takes reasonable precautions to ensure that the Rx drug order will be handled in a manner consistent with federal and state statutes regarding the handling of PHI - The pharmacy from which the Rx drug order will be dispensed has relevant and appropriate policies and procedures in place and makes them available to the board upon request

A licensed pharmacist may not supervise > _____ intern who is performing tasks associated with dispensing or cmpding. In the case of an internship experience conducted as part of the experiential education program of an accredited college or SOP, a licensed pharmacist may supervise _____ interns who are performing tasks associated with dispensing or compounding.

1, 2

How many hours of practical pharmacy experience under the instruction of a licensed pharmacist are required for licensure?

1,600 (800 of those being in traditional cmpding and dispensing) If obtaining license by reciprocity and deficient in internship hours, any hours worked as a licensed pharmacist will count towards the deficiency. The board may compel applicants who have not engaged in practice as a licensed pharmacist for the two years immediately preceding the time of filing of their application for reciprocity to take the NAPLEX examination.

A pharmacy technician must report any changes in name, residence, or place of employment to the board w/in _____ days of the change.

10

A registered pharmacy or a licensed pharmacist may sell, w/out the Rx or direction of a practitioner, unused hypodermic needles and syringes in quantities of _____ or fewer.

10 Must keep needles/syringes out of public access and notify Commissioner of Health of participation and disposal activity

For cease and desist orders, a hearing must be held not later than _____ days after the request for the hearing is received by the board. After the completion of the hearing, the administrative law judge shall issue a report within _____ days. Within _____ days after receiving the report of the administrative law judge, the board shall issue a further order vacating or making permanent the cease and desist order. If no hearing is requested within _____ days of service of the order, the cease and desist order will become permanent.

10, 10, 15, 30 The time periods provided in this provision may be waived by agreement of the executive director of the board and the person against whom the cease and desist order was issued. If the person to whom a cease and desist order is issued fails to appear at the hearing after being duly notified, the person is in default. A cease and desist order issued under this subdivision remains in effect until it is modified or vacated by the board.

No prescription drug order may be filled or refilled more than _____ months after the date on which it was issued.

12 RFs originally authorized in excess of 12 months are void 12 months after the original date of issuance of the Rx drug order. After 12 months from the date of issuance of a Rx drug order, no additional authorizations may be accepted for that Rx drug order. If the prescriber desires continued therapy, a new Rx drug order must be generated and a new Rx number assigned.

A drug may only be dispensed to a pt as an emergency Rx once in what timeframe?

12 mo

How long is PMP data available to permissible users?

12 months (effective Jan 1 2020) Data reported during the period January 1, 2015, through December 31, 2018, may be retained through December 31, 2019, in an identifiable manner. Effective January 1, 2020, data older than 24 months must be destroyed. Data reported on or after January 1, 2020, must be destroyed no later than 12 months from the date the data was received.

Other vaccines minimum age

13 YO

The BOP must be notified of intended closing at least _____ days prior to ceasing operations.

14

How many PO drugs may be stocked in an emergency kit at one time? What is the exception?

15 PO ABX - Unlimited number of 72 hr supplies allowed

Minimum age to register as a pharmacy technician

18 YO

Intern: Pharmacist Ratio: Dispensing and cmpding w/in a licensed pharmacy

1:1 - except that when at least 1 intern is completing an experiential rotation through a college of pharmacy, the ratio can be 2:1 In situations where an intern is giving immunizations but also participating in compounding and dispensing, the lowest applicable ratio applies.

Any person who has been licensed by the board and has defaulted in the payment of the renewal fee may be reinstated w/in _____ yrs of such default without examination.

2

For drugs repackaged by a contract pharmacy from a bulk Rx container from an original dispensing pharmacy for a LTCF resident, records of the following information must be maintained x at least _____ yrs:

2 - Drug name - Mfr - Mfr's lot number - Mfr's exp date - Qty - Name of resident - Address of resident - Name of prescriber - Address/other identifier of prescriber - Date Rx issued - Date drug repackaged - Date repackaged drug delivered to LTCF - SIG - Copy of label affixed to repackaged drug - Initials of packager - Initials of supervising pharmacist - Name of original dispensing pharmacy - Address of original dispensing pharmacy

A facility must keep a complete record of CS use in emergency kits x _____ yrs. Information in these records must include:

2 - Pt's name - Date of use - Name of the drug used - Strength of the drug - Number of doses used - Signature of the person administering the dose

OTC methamphetamine precursor limits - single sale

2 pkgs (6 g) total base (federal more strict - 3.6 g) Each pkg must contain 3 g base or less and blisters must not contain > 2 dosage units

For new Rxs, a pharmacy must develop and implement a written quality assurance plan that includes a pharmacist or intern comparing the original written Rx or an image of the original written Rx to the information entered into the computer, and documenting the completion and accuracy of this comparison with the date and unique identifier of the pharmacist or intern completing the task. This process must not occur prior to _____ hours after the Rx has been initially certified, unless _____. The process must be completed within _____ hours.

2, it is completed by a second individual pharmacist as soon as possible after the initial certification has occurred, 72 As an alternative, hospitals providing inpt pharmacy services may elect instead to develop a plan to provide safeguards against errors being made and perpetuated due to inaccurate Rx data being entered into the pharmacy's computer. This written quality assurance plan shall be made available to the board surveyors upon request.

_____ hours CE must be submitted to the board by _____ on (even, odd)-numbered years for technicians.

20, July 30, odd A pharmacist or pharmacy technician may apply for credit for attendance at programs not previously submitted to the board for approval provided that the pharmacist or pharmacy technician completes a continuing education program approval form, obtainable from the board, and submits it to the board within 90 days after completing the program.

A pharmacy in MN must contain > _____ sq ft in the dispensing and drug storage area.

250 May be waived for satellite pharmacies in hospitals

Intern:Pharmacist Ratio - Vaccines

2:1

The board shall maintain a log of all persons who access the PMP x at least _____ yrs and shall ensure that any permissible user has and maintains a PMP acct.

3

How many times may the NAPLEX be taken? How long does the applicant have to complete the licensing process after an application is submitted?

3 (may petition for more), 18 months

A permissible user who delegates access to the PMP to an agent or employee shall terminate that individual's access to the data w/in _____ of the agent or employee leaving employment with the permissible user. The board may conduct random audits to determine compliance with this requirement.

3 business days

An individual licensed or registered by the board shall maintain a current name and home address w/ the board and shall notify the board in writing w/in _____ days of any change in name or home address.

30

How many days does the PIC have to respond to a deficiency report?

30 Failure to submit in writing the steps taken/proposed to eliminate the deficiency or to eliminate deficiency shall be grounds for the institution of disciplinary action by the board.

No Rx for a CII-IV opiate or narcotic pain reliever may be initially dispensed > _____ after the date on which the Rx was issued. No subsequent RFs indicated on an Rx for a CIII or CIV opiate or narcotic pain reliever may be dispensed > _____ after the previous date on which the prescription was initially filled or RF'd.

30 days, 30 days (based on date Rx processed and prepared for dispensing, not sold) After the authorized RFs for CIII or CIV opiate or narcotic pain relievers have been used up or are expired, no additional authorizations may be accepted for that Rx. If continued therapy is necessary, a new Rx must be issued by the prescriber. Rxs for CIII-IV opiates can still have up to 5 RFs w/in 6 mo. However, each RF must be dispensed no > 30 days after the last RF was dispensed May p/u Rx after 30 days if requested prior to 30 days, but use professional judgement on appropriateness of timing Will affect issuance of multiple Rxs for OPIATES. Other CIIs (e.g. Adderall) can still be written as multiple Rxs w/ a MAX 90 DS For CIII and IV opiates, a prescriber can authorize RFs but must specify each fill must last 90 days

The board shall conduct random audits, on at least a quarterly basis, of electronic access of the PMP by permissible users to ensure compliance with permissible use. A permissible user whose account has been selected for a random audit shall respond to an inquiry by the board, no later than _____ after receipt of notice that an audit is being conducted. Failure to respond may result in _____.

30 days, deactivation of access to the electronic system and referral to the appropriate health licensing board, or the commissioner of human services, for further action.

A facility licensed or registered by the board shall maintain a current name and address with the board. A facility shall notify the board in writing w/in _____ days of any change in name. A facility licensed or registered by the board but located OUSTIDE of the state must notify the board w/in _____ days of an address change. A facility licensed or registered by the board and located W/IN the state must notify the board at least _____ days in advance of a change of address that will result from the move of the facility to a different location and must pass an inspection at the new location as required by the board.

30, 30, 60

_____ hours CE must be submitted to the board by _____ on (even, odd)-numbered years for pharmacists.

30, September 30, even A pharmacist or pharmacy technician may apply for credit for attendance at programs not previously submitted to the board for approval provided that the pharmacist or pharmacy technician completes a continuing education program approval form, obtainable from the board, and submits it to the board within 90 days after completing the program. No specific state CE requirements at this time.

How long is a BOP member's term, and what day of the year do they end?

4 yrs First Monday in January

A pharmacy engaged in the dispensing of outpt IV admixtures shall develop a _____-year audit trail system that will identify the dispensing pharmacist for each unit dispensed.

5

The PIC of an on-site pharmacy in a hospital shall be engaged by the hospital and shall provide at least part-time, _____-day/wk services.

5

W/in _____ business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the name and mfr of the biological product dispensed. In what situations is this communication not requried?

5 - There is no FDA-approved interchangeable biological product for the product prescribed - The biological product being dispensed as a RF and is the same product dispensed on the prior filling

Unless the fax transmission is received on a machine generating a copy that is readily readable for at least _____ years, all fax transmissions of Rx drug orders shall be followed up within _____ hrs w/ the original hard copy of the order or the pharmacist shall reduce the order received by fax to writing that is of permanent quality.

5, 72 Note: Rx drug orders for CII-IVs received by fax shall be handled according to the rules of the DEA.

Influenza vaccine minimum age

6 YO

OTC methamphetamine precursor limits - 30 day period

6 g (federal 9 g)

An emergency kit may not contain > _____ of any CS narcotic analgesic

6 single doses

Appropriate documentation must be submitted to the BOP at least _____ days prior to a proposed change in location, change in dimension/security, or establishment of satellite.

60 No additional charge shall be made for the new license for a change in location. Failure of the board to respond in writing within 30 days shall be considered to be approval of the proposed changes in dimension/security. Failure of the board to respond in writing within 60 days shall be considered to be approval of the proposed satellite.

CII Rx drug orders for pts in a LTCF and terminally ill patients shall be valid for a period NTE _____ days from the issue date unless terminated sooner by the discontinuance of medication.

60 The total qty of CII drugs dispensed in all partial dispensings must not exceed the total qty prescribed.

If a product is assigned an exp date > _____ days from its cmpding date, there must be in-house data or data in the literature to assure the sterility and stability of the product when it is used by the pt.

7

A permissible user who has delegated the task of accessing the PMP to an agent or employee shall audit the use of the electronic system by delegated agents or employees on at least a quarterly basis to ensure compliance with permissible use. When a delegated agent or employee has been identified as inappropriately accessing data, the permissible user must immediately remove access for that individual and notify the board w/in _____.

7 days

Statute of Limitations

7 yrs

Drugs used from an emergency kit shall be replaced by submitting an Rx drug order for the used item to the pharmacist within _____ hours and the supply shall be resealed by the pharmacist or the pharmacist's agent.

72

If dispensing information is lost due to unscheduled system interruption, the BOP shall be notified within _____ hours.

72

After dispensing an emergency Rx, the pharmacist must notify the practitioner who issued the Rx drug order not later than _____ after the drug is sold or dispensed. The pharmacist must request and receive authorization before any additional RFs may be dispensed. If the practitioner declines to provide authorization for additional RFs, the pharmacist must inform the pt of that fact.

72 hrs

Pharmacies must be lighted to a level of not < _____ foot-candles in major work areas.

75

After a pt has obtained an initial 30 DS of an Rx drug, and the pt returns to the pharmacy to obtain a RF, a pharmacist may dispense up to a _____ DS of that Rx drug to the pt when the following requirements are met:

90 - The total qty of dosage units dispensed by the pharmacist does not exceed the total quantity of dosage units of the remaining RFs authorized by the prescriber - The pharmacist is exercising the pharmacist's professional judgment - The initial 30 DS requirement is not required if the Rx has previously been filled with a 90 DS - A pharmacist may not exceed the number of dosage units authorized by a prescriber for an initial prescription or subsequent RFs if: - The prescriber has specified on the Rx that, due to medical necessity, the pharmacist may not exceed the number of dosage units identified on the Rx - The Rx drug is a CS

Other than a pharmacist, who may access the pharmacy in the case of an emergency for the withdrawal of limited qtys of medications for hospital inpts? What documentation must this person leave for the pharmacist?

A designated RN Withdrawing from a bulk stock container: - Pt's name - Name of drug - Strength of drug - Dose prescribed s - Amnt taken - Date - Time - Signature of nurse withdrawing drug Withdrawing the drug from a bulk stock container or unit dose packaging bin shall place upon the record of withdrawal the container from which the limited doses were taken so that the withdrawal may be verified by the pharmacist.

For a faxed Rx, the procedures must provide for the identification of the person sending the Rx drug order except for:

A pharmacy other than a hospital pharmacy that is transmitting solely within the institution,

Practitioner dispensing requirements

A practitioner engaged in dispensing drugs shall keep on file at each location from which dispensing is taking place a record of drugs received, administered, dispensed, sold, or distributed. The records shall be readily retrievable, shall be maintained x at least 2 yrs, and shall include: - A record or invoice of all drugs received for purposes of dispensing to pts - An Rx record of drugs dispensed, filed by Rx number or date, showing the: - Pt's name - Pt's address - Date of Rx - Name of drug - Strength of drug - Qty dispensed - SIG - Signature of practitioner - DEA number (if CS) - A record of RFs recorded on the back of the Rxs showing: - Date of RF - Qty dispensed - Initials of dispenser - Pt profile requirements of part 6800.3110, if all data required by that part is not already included in the pt's chart

A pt who has been prescribed a CS may access the PMP database in order to obtain what information? What must the pt do to obtain this information?

Access by permissible users to the pt's data record, including the name and organizational affiliation of the permissible user and the date of access Pt must complete, notarize, and submit a request form developed by the board. The board shall make this form available to the public on the board's website.

For what activities is immediate and direct supervision of an intern required by a licensed pharmacist?

Activities related to cmpding and dispensing Immediate and direct supervision by a licensed pharmacist is not required when an intern completes a medication hx, gathers information for the purpose of formulating a pharmaceutical care plan or making a drug therapy recommendation, conducts educational activities for pts or staff, provides pt counseling, participates in pt rounds, or performs similar tasks that do not involve dispensing and cmpding. However, all drug therapy and related recommendations that an intern proposes to make to other HCPs and pts must be reviewed and approved by a licensed pharmacist before they are made. An intern's supervising pharmacist is responsible for the accuracy and completeness of statements made by the intern while providing counseling to pts or health-related education to pts or staff.

Chart Order - Definition and Required Components

An Rx drug order for a drug that is to be dispensed by a pharmacist, or by a pharmacist-intern under the direct supervision of a pharmacist, and administered by an authorized person only during the patient's stay in a hospital or LTCF Must contain: -Name of the pt -Secondary pt identifier (e.g. DOB or MRN) -Drug ordered -Directions for use concerning strength, dosage, frequency, and ROA -Manual or electronic signature of the practitioner -must be affixed to the chart order at the time it is written (later date okay if verbal)

To obtain a pharmacy license as a parenteral-enteral home health care pharmacy, a policy and procedures manual shall be available for inspection at the pharmacy. The manual shall be reviewed and revised on a(n) _____ basis.

Annual

How often must a registrant who engages in research, teaching, or educational projects involving the use, study, or testing of CSs conduct inventory?

Annually

The BOP may inspect and make copies of which types of records?

Any and all records of shipment, purchase, mfr, quality control, and sale of these items provided Shall NOT extend to financial data, sales data, or pricing data

Notice for impairment of ability of user to operate a motor vehicle must be prominently displayed on which types of Rxs? When is the notice not required for these Rxs?

Any drug containing a CS, or any other drug determined by the board, either alone or in conjunction with alcoholic beverages, may impair the ability of the user to operate a motor vehicle Not required if there is evidence that user will not operate a motor vehicle

How long do records showing who filled/checked Rxs need to be kept?

At least 2 yrs

How long must ADC Certification Records be kept?

At least 2 yrs A pharmacist must certify all packaging, labeling, and stocking associated with the use of an ADC. Unless the certification process utilizes a fail-safe bar coding, certification must be performed by a pharmacist.

How long must the PIC maintain documentation of technician training in the pharmacy?

At least 2 yrs after the training occurs

How often must a LAFW be inspected?

At least Q12M

How often must the PIC update written procedures for the use of pharmacy technicians?

At least Q5Y and whenever a significant change in the way in which pharmacy technicians are utilized occurs.

How often must the supplying pharmacy inspect an emergency kit for use in parenteral/enteral home healthcare? How soon must any drugs used from the kit be replaced?

At least Q60D W/in 72 hrs

How often must pharmacy personnel conduct a CS audit on an ADC?

At least monthly

PMP Advisory Task Force Members

At least one representative of: - DOH - DHS - Each HRLB that licenses prescribers - A professional medical association, which may include an association of pain mgmt and chemical dependency specialists - A professional pharmacy association - A professional nursing association - A professional dental association - A consumer privacy or security advocate - A consumer or pt rights organization - An association of MEs and coroners

Who has to register and maintain a user acct w/ the PMP? What information is private?

By July 1, 2017: - Every prescriber licensed by a HRLB, practicing within this state who is authorized to prescribe CSs for HUMANS and who holds a current DEA registration - Every pharmacist licensed by the board and practicing w/in the state Data submitted by a prescriber, pharmacist, or their delegate during the registration application process, other than their name, license number, and license type, is classified as private

Limit on qty of opiates prescribed - dental pain

Rxs for CII-IV opiates or narcotic pain relievers shall not exceed a 4 DS

Limit on qty of opiates prescribed - acute pain

Rxs for CII-IV opiates or narcotic pain relievers shall not exceed a 7 DS (adult) or a 5 DS (< 18 YO) Acute pain does not include chronic pain or pain being treated as part of cancer care, palliative care, or hospice or other end-of-life care Prescriber may prescribe more than these limits if deemed necessary in their professional judgement

Who may make changes on the SIG for LTCF Rxs?

SIGs on labels of medications shall be changed only by a pharmacist acting on the instructions of the prescriber or the prescriber's agent. Personnel of the facility may affix supplemental labels alerting staff to a change in the SIG when a corresponding change is made on the appropriate MAR, in accordance with procedures approved by the facility's quality assurance and assessment committee. Subsequent RFs of the medication shall be appropriately labeled with the SIG in effect at the time of dispensing.

The president and vice president of the BOP must be members, but the _____ may or may not be a member.

Secretary Must be a pharmacist

If bulk compounding of parenteral solutions is performed using nonsterile chemicals, extensive end-product testing must be documented before release of the product from quarantine. The process must include testing for _____ and _____.

Sterility, pyrogens

T or F - A pharmacist shall post the license or renewal most recently issued by the board or a copy of it in a conspicuous place within the pharmacy in which the pharmacist is practicing.

T

T or F - A pharmacy must develop a list of high-alert cmpded preparations for which a pharmacist shall certify that each component used in the cmpding of the drug preparation has been accurately weighed, measured, or subdivided, as appropriate, at each stage of the cmpding procedure in order to verify conformance with the formula being prepared. Subsequent stages of the cmpding process may not be completed until this certification occurs.

T

T or F - A pharmacy utilizing a central service pharmacy to provide dispensing functions, DUR, packaging, labeling, delivery of a completed Rx drug order, or other services must notify its patients of that fact.

T

T or F - A pharmacy utilizing a central service pharmacy to provide dispensing functions, DUR, packaging, labeling, delivery of a filled Rx, or other services must notify the pharmacy's patients of that fact.

T

T or F - A practitioner shall reduce all drug orders to a written Rx that shall be numbered and filed in an organized manner when dispensed. Patient chart records do not qualify as a prescription record.

T

T or F - As long as a prescriber practicing medicine, dentistry, or veterinary medicine is only administering or furnishing the pt w/ properly labeled/pkg'd drugs and not dispensing/selling drugs, they are not subject to inspections by the BOP.

T

T or F - Each pharmacy license shall be posted in a conspicuous place in the pharmacy for which the license has been issued.

T

T or F - For LTCFs, faxed or electronic Rxs should be utilized whenever possible (except CIIs, which need to be written and manually signed by the prescriber except in the case of an emergency).

T

T or F - If an Rx has been certified by a pharmacist at a licensed central service pharmacy, in compliance with MN BOP rules, an additional certification is not required at the pharmacy that dispenses, mails, or ships the completed prescription to the patient.

T

T or F - One profile record may be maintained for all members of a family living at the same address and possessing the same family name.

T

T or F - Requests for CRCW must be documented.

T

T or F - The board may participate in an interstate PMP data exchange system provided that permissible users in other states have access to the data only as allowed by MN law.

T

T or F - The use of an open matrix drawer in an ADC that allows access to > 1 drug at a time must be limited to non-CS drugs, unless the entire drawer contains only one CS drug product.

T

T or F - An emeritus pharmacist is not subject to renewal fees or continuing education requirements.

T An emeritus license is not a license to practice, but is a formal recognition of completion of that individual's pharmacy career in good standing.

T or F - Separate licenses are required and are not transferable.

T - A separate license shall be required for each pharmacy and is not transferable. The following shall be considered a transfer of ownership requiring re-licensure: A. Sale of all or substantially all of the assets of the pharmacy B. Addition/deletion of one or more partners in a partnership to which a pharmacy license has been issued C. Change of ownership of 20% or more of the issued voting stock of a corporation pharmacy since the issuance of the license or the last renewal (does not apply to any corporation the voting stock of which is actively traded on any securities exchange or in any OTC market D. Change in ownership from one form to another: sole proprietor, partnership, or corporation.

T or F - Podiatrists can diagnose and treat medically, mechanically, and surgically the ailments of the human hand, foot, ankle, and lower leg.

T - Can't treat hands in all states, but can in MN

T or F - Only a pharmacist that has completed immunization training may supervise an intern administering a vaccine.

T - Physicians, nurses, or other HCPs may not supervise interns when administering vaccines.

Pharmacy Operations While Pharmacist is on Break

Technicians, interns, and other supportive staff, authorized by the pharmacist on duty, may continue to perform duties as allowed: - No duties reserved to pharmacists and interns that require the professional judgment of a pharmacist, may be performed by pharmacy technicians or other supportive staff - Only Rxs that have been certified by a pharmacist may be dispensed while the pharmacist is on break; except that Rxs that require counseling by a pharmacist may be dispensed only if the following conditions are met: - The pharmacy develops a list of drugs that may not be dispensed while a pharmacist is on break, without the patient receiving counseling from a pharmacist, when counseling would normally be required - The pt, or other individual who is picking up the Rx on behalf of the patient, is told that the pharmacist is on a break and is offered the chance to wait until the pharmacist returns from break in order to receive counseling - If the pt or caregiver declines to wait, a telephone number at which the pt or a caregiver can be reached is obtained - After returning from the break, the pharmacist makes a reasonable effort to contact the patient or a caregiver by telephone and provides counseling - The pharmacist documents the counseling that was provided or documents why counseling was not provided, including a description of the efforts made to contact the pt or caregiver. The documentation shall be retained made available for inspection x at least 2 yrs.

Who may designate prescribers for mass prescribing in the case of a national emergency where large scale prophylactic drugs/vaccines are required?

The Commissioner of Health

Expiration date of the PMP Advisory Task Force

The PMP Advisory Task Force shall not expire

How many days prior to use of an automated counting device/distribution system does a pharmacy need to notify the BOP and what information is required in the notification? If the BOP does not notify the pharmacy w/in _____ days that an automated counting device/distribution system cannot be used, the pharmacy may proceed with use as planned.

The board must be provided with written notification of the location of the automated counting device or automated drug distribution system, the name and address of the pharmacy responsible for control of the device or system, written policies and procedures that govern the operation of the device or system, and the name of the PIC of the pharmacy. Notification must be provided to the board at least 60 days in advance of the initial use of the device or system. 60 - The written notification must specify the steps that the pharmacy must take in order to use the system.

Acceptable use of the PMP

The database may be used by permissible users for the identification of: - Individuals receiving Rxs for CSs from prescribers who subsequently obtain CSs from dispensers in qty's or w/ a frequency inconsistent with generally recognized stds of use, including stds accepted by national and international pain management associations - Individuals presenting forged or otherwise false or altered Rxs for CSs to dispensers No permissible user may access the database for the sole purpose of identifying prescribers of CSs for unusual or excessive prescribing patterns w/out a valid search warrant or court order No personnel of a state or federal occupational licensing board or agency may access the database for the purpose of obtaining information to be used to initiate a disciplinary action against a prescriber

Security requirements for a hospital pharmacy

The pharmacy or drug room shall be surrounded by a continuous partition or wall extending from floor to ceiling. All doors and windows shall be securely locked when the pharmacy or drug room is closed, so as to prevent entry by unauthorized persons.

What is the allowable qty for each drug stocked in an emergency kit?

Up to 72 hrs worth

What must the dispenser obtain from the purchaser when selling a CS?

Valid photo ID - unless purchaser is known to dispenser

In what case may prescribers be involved in setting the price of filled Rx orders? When is pt notification required?

Veterinarians may enter into price-setting agreements w/ a pharmacy provided the client or other person paying for the Rx is notified, in writing and with each Rx dispensed, about the arrangement Notification NOT required for pharmacy services provided for livestock, poultry, and agricultural production systems

What must a pharmacist do before dispensing a donated drug from the drug repository to a pt?

Visually inspect the drug or supply for adulteration, misbranding, tampering, and date of exp. Drugs or supplies that have expired or appear upon visual inspection to be adulterated, misbranded, or tampered with in any way must not be dispensed or administered. Pt must sign acknowledgement form found on BOP website

When does a pharmacist not need to comply w/ guidelines for vaccines and immunizations established by the ACIP?

hen administering a vaccine pursuant to a valid, pt-specific order issued by a physician/PA authorized to prescribe/APRN authorized to prescribe provided that the order is consistent with the FDA-approved labeling of the vaccine.

Pharmacists must utilize the MN Immunization Information Connection to assess the immunization status of individuals prior to the administration of vaccines, except when administering _____ vaccines to individuals age _____ and older

influenza, 9

Commingling of returned medication or mixing of lot numbers of returned medication, upon or prior to repackaging, shall result in such medication being deemed _____.

misbranded and subject to embargo Does not apply to the return of medical devices provided that proper sanitary procedures are used prior to reuse, resale, or re-rent

Required BSC type for cmpding cytotoxic drugs

vertical flow, Class II BSC

The PIC of a drug room in a hospital shall schedule on-premises visits on at least a _____ basis.

weekly

How long can a new owner continue operation of a pharmacy under the license issued to the prior owner in the case of a txfer of ownership?

x 14 days after the effective date of the change of ownership or until the board issues a new license, whichever is earlier After the 14-day period, the license issued to the prior owner is void and must be surrendered to the director of the board. The new owner must submit a completed pharmacy license application prior to the effective date of the txfer.

How long must the txferring pharmacy keep the original Rx drug order on file? How long must thee receiving pharmacy keep the txferred Rx drug order on file?

x at least 2 yrs from the date of last filling (both txferring and receiving)

How long must a pharmacy retain records of OTC methamphetamine precursor sales?

x at least 3 yrs Times sold must at all reasonable times be open to the inspection of any law enforcement agency.

How long must records related to the drug repository program be maintained?

x at least 5 yrs

Each pharmacy shall maintain a perpetual inventory system for _____. The system shall be established in a manner that will provide total accountability in all aspects of drug distribution. The inventory shall be reconciled with the actual inventory _____ and the reconciliations shall be documented. Reconciliation documentation shall be retained x at least _____ yrs.

CIIs, monthly, 2

Criteria for utilizing an oral order reduced to writing for a CII in a LTCF setting

Can only be done in emergencies, otherwise needs to be written and manually signed by the prescriber Criteria for an "emergency"*: - Immediate administration is necessary for the proper tx of the intended ultimate user - No appropriate alternative tx is available, including administration of a drug which is not a CS - It is not reasonably possible for the prescribing practitioner to provide a written Rx drug order to be presented to the person dispensing the CS, prior to dispensing. *also true for use of CSs from an emergency kit

When does a legend medical gas certificate expire? How often must certificates be renewed?

Dec 1 Annually Change in location requires reregistration

A pharmacy technician registration expires each year on _____ and shall be renewed annually by filing an application for registration renewal on or before _____ of each year

December 31, December 1 Must pay a late fee of 50% of the renewal fee in addition to the renewal fee if application is submitted after due date.

Distressed drugs definition

Drugs or medicines which have been subjected to accident, fire, flood, adverse temperatures, or other physical influences which could affect the potency, quality, purity, or efficacy of such drug or medicine could otherwise cause the drug or medicine to be adulterated or misbranded No person shall sell, barter, vend, give away, or exchange distressed drugs until the board has determined that such drugs are not adulterated or misbranded

T or F - A LTCF may donate a drug to a central or local repository even when federal or state law requires the drug to be returned to the pharmacy that initially dispensed it so that the pharmacy can credit the payer for the amount of the drug returned.

F

T or F - CII Rxs may be txferred between pharmacies.

F

T or F - Rxs faxed to the pharmacy by the pt may be filled and dispensed.

F

T or F - Unused drugs repackaged by a contract pharmacy from a bulk Rx container from an original dispensing pharmacy for a LTCF resident may be returned to either pharmacy and reused.

F

T or F - An Rx drug order is required for a pharmacy to dispense a research drug.

F (unless required by the study protocol) Any qualified person may use legend drugs in the course of a bona fide research project, but cannot administer or dispense such drugs to human beings unless such drugs are prescribed, dispensed, and administered by a person lawfully authorized to do so.

T or F - A separate license is required for each satellite pharmacy w/in a hospital

F - A licensed pharmacy in a hospital may utilize additional locations within the hospital w/out the necessity of securing additional licenses provided, however, that the PIC informs the board of the location of each satellite and assumes professional responsibility for each location.

T or F - When a drug is dispensed in an Rx vial, a BUD needs to be printed on the label.

F - Drugs dispensed in prescription vials that are labeled with a beyond-use date shall bear a beyond-use date of not more than one year from the dispensing date or the time remaining to the manufacturer's expiration date, whichever is less.

T or F - A pharmacy may txfer a CS that has been profiled but not actually dispensed.

F - Electronic, paper, faxed or verbal controlled substance prescriptions cannot be transferred unless they have been filled at least once. Electronically prescribed controlled substance prescriptions that have not been filled can be forwarded - but only electronically (forwarding includes CIIs). Since this is the official DEA interpretation of federal rules, the Board expects pharmacies to act accordingly.

T or F - All vaccines in MN must be reported to MIIC.

F - If a pt opts out, your intent to report fulfills the reporting requirement.

T or F - Licensing of a pharmacy in > 1 category results in an increase in the license fee.

F - Licensing of a pharmacy in > 1 category shall not result in an increase in the license fee. No pharmacy may engage in providing products or services in categories for which it is not licensed. A pharmacy must designate its category or categories on license renewal or application for an initial license.

T or F - Prescribers may have a default DAW setting on electronic Rxs.

F - Must state DAW on each individual Rx

T or F - A pharmacist can be the designated PIC at > 1 pharmacy.

F - No pharmacist shall be designated PIC of more than one pharmacy. Exception: In the interest of public health, this requirement may be waived in the case of a pharmacist serving a hospital pharmacy on a part-time basis.

T or F - A provider's DATA 2000 waiver DEA number should be reported to the MN PMP in place of their regular DEA registration for buprenorphine Rxs for tx of opioid dependence.

F - ONLY enter regular DEA registration number in the PMP

T or F - The marketing, advertising, or labeling of a product containing ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine for the indication of stimulation, mental alertness, weight loss, appetite control, or energy, is allowed provided nothing in the labeling states that the product is intended to cure any disease.

F - This is prohibited Does not apply to products containing ephedra or ma huang and lawfully marketed as dietary supplements under federal law.

T or F - All third party logistics providers must be licensed, even if they only handle OTC products.

F - Use of the word "drug" not in definition Note that the definition of wholesaler distribution uses the word "drug" - so wholesalers of OTC drugs do have to be licensed.

T or F - A pharmacist w/ an inactive license may not practice pharmacy in MN, but must continue to pay the renewal fee and comply w/ CE requirements.

F - must still pay renewal fee, but does NOT have to comply w/ CE requirements

T or F - All unit-dosed drugs must be stored in a locked area or locked cart at all times.

F - only applies to CSs. All non-CSs must be stored in a locked area or locked cart when a pt care area is not staffed. An area in which staff is actively providing pt care or preparing to receive pts is considered a secure area and locked storage of non-CSs is not required.

T or F - A pharmacy outside of MN may mail Rxs to a pt in MN w/out being licensed by the MN BOP.

False - No person or persons shall conduct a pharmacy in or outside of MN that dispenses legend drugs for MN residents and mails, ships, or delivers the legend drugs into the state unless the pharmacy is licensed by the BOP

Who appoints members of the BOP

Governor

Which CS schedules may an optometrist prescribe?

IV and V

How soon must CS losses be reported to the DEA? What information must be included in the written report?

Immediately - Description of how the loss occurred, if known - Date the loss occurred, if known - Steps being taken to prevent future losses - Inventory of the missing drugs

In what situations may medications be returned to and reused by a pharmacy?

In a hospital with a licensed pharmacy, drugs, devices, or other items dispensed for hospital inpatient use only, which have not left the span of control of the pharmacy Drugs from nursing homes and assisted living facilities may be returned to the dispensing pharmacy if: - The consultant pharmacist can assure proper storage conditions for the drugs in the facility as specified in USP and the drugs are stored securely w/in the facility - The facility has 24-hr, on-site licensed nursing coverage 7 days/wk - The drugs are returned to the dispensing pharmacy - No reconstituted drugs, drugs requiring refrigeration, or CSs may be returned - The drugs are received by the pharmacy in the original mfr's packaging or pharmacist packager's unit-dose, unit-of-use, or strip packaging w/ each tablet or capsule individually wrapped and labeled, or in blister cards, which indicate the drug name and strength, the packager's name, and the manufacturer's or packager's lot or batch number - Pharmacy must be able to demonstrate to the board that its packaging material and procedures will provide a package that will meet or exceed the criteria for class B packaging established by USP, and that procedures have been developed and implemented to prevent the commingling of dosage units of different lot numbers or BUDs.

What pharmacy personnel may complete a txfer?

Information must be communicated directly by one licensed pharmacist or registered intern to another licensed pharmacist or registered intern.

Who must complete an internship manual provided by the BOP?

Interns completing > 400 internship hrs in MN

If the appointing authority fails to appoint a successor by _____ of the year in which the term expires, the term of the BOP member for whom a successor has not been appointed shall extend until ____ ____ yrs after the scheduled end of the original term.

July 1, the first Monday in January, 4

A person who engages in research, teaching, or educational projects involving the use, study, or testing of CSs shall annually, on or before _____ of each year, apply for registration by the board.

June 1

Each pharmacy license shall expire on _____ of each year and shall be renewed annually by filing an application for license renewal, on or before _____ of each year.

June 30, June 1 Renewal applications received on or after July 1 are subject to a late filing fee of an amount equal to 50% of the renewal fee in addition to the renewal fee.

Advertising Requirements

Legend drug price information may be provided to the public only by a pharmacy, so long as it is not violative of any federal or state laws applicable to the advertisement of such articles generally and if all of the following conditions are met: - No representation or suggestion concerning the drug's safety, effectiveness, indications for use, or competitive comparison shall be made. - No reference shall be made to CII-IVs - Termination date for the prices listed shall be stated in the ad

What organization enforces hazardous pharmaceutical waste disposal?

MN Pollution Control Agency (MPCA)

A pharmacist license expires on _____ of each year and shall be renewed annually by filing an application for license renewal on or before _____ of each year, together with a fee of $105.

March 1, February 1 A pharmacist license renewal application received after March 1 is subject to a late filing fee of an amount equal to 50% of the renewal fee in addition to the renewal fee.

Requirements for reactivation of an inactive license

May show compliance w/ CE requirement if actively licensed and in good standing in another state that requires CE If not actively licensed and in good standing in another state that requires CE, must show that CE has been completed at a rate of 15 hrs/yr x each year that the license has been on inactive status up to a MAX of 75 hrs If inactive > 5 yrs, must re-take MN MPJE

Labeling requirements for legend medical gases

Mfr's intact federally required labeling

How often must the pharmacy conduct inventory on emergency kits?

Monthly

How much may a contract pharmacy charge for a handling fee when repackaging medication from a bulk Rx container from an original dispensing pharmacy for a LTCF?

Monthly fee of no > 250% of the medical assistance program dispensing fee for each drug repackaged, but no > $100/mo for each individual resident

Pharmacy Security Requirements (for when the pharmacy is closed)

Must be surrounded by a continuous partition or wall extending from the floor to the permanent ceiling, containing doors capable of being securely locked to prevent entry when the pharmacy is closed

Valid Rx Required Components

Must be written/printed on paper, an oral order reduced to writing by a pharmacist, or an electronic order Must be issued for an individual pt by a practitioner w/in the scope and usual course of the practitioner's practice Must contain: -Date of issue -Name and address of pt -Name and qty of drug prescribed -Directions for use -Name and address of practitioner -Practitioner's telephone number -Practitioner's manual signature (written/printed/fax) or electronic signature (electronic)

Testing requirements mfrs must meet for the sale of non-intoxicating cannabinoids extracted from hemp other than food that is intended for human or animal consumption

Must confirm that the product: - Contains the amnt or % of cannabinoids that is stated on the label of the product - Does not contain > trace amounts of any pesticides, fertilizers, or heavy metals - Does not contain a [delta-9 THC] that exceeds 0.3% on a dry weight basis

Limitation on Continuous Hours Worked and Break Requirements

No pharmacy employee shall be required to work > 12 continuous hrs/day, inclusive of breaks - 30 min if > 6 hr shift - Must be provided adequate time to use restroom w/in each 4 consecutive hrs - Above not applicable if emergency necessitates working longer than 12 hrs or break interruptions Pharmacy may, but is not required to close when pharmacist is on break - If pharmacy closes, pharmacist must remain in pharmacy/establishment to be available for emergencies - If multiple pharmacists, breaks should be staggered

How long must pt profiles be maintained?

Not less than 2 yrs from date of last entry May be in hard copy or computerized form

How soon must a pharmacist/intern notify the BOP of a change in location of employment or residence address?

Notify BOP in writing immediately and no > 30 days

Cmpding rules for bulk substances do not apply to which types of cmpds?

PET drugs and radiopharmaceuticals

What CSs may NOT be used in emergency kits?

PO stimulants

What pharmacy personnel may retrieve an Rx transmitted to a pharmacy's answering machine or an electronic voice recording device?

Pharmacists and Interns Considered verbal Rx orders and must be reduced to writing Technicians may do so ONLY if the practitioner or authorized agent of the practitioner is approving additional RFs of an Rx previously dispensed from the pharmacy and no other changes are made to the Rx. Clerks may not receive Rx information from these devices

What types of practitioners must an immunization protocol be under?

Physicians, PAs, APRNs

A pharmacist may interpret the results of laboratory tests but may modify drug therapy only pursuant to a _____ or _____.

Protocol, Collaborative Practice Agreement Any changes in drug therapy or medication administration made pursuant to a protocol or collaborative practice agreement must be documented by the pharmacist in the pt's medical record or reported by the pharmacist to a practitioner responsible for the pt's care.

Health Professionals Services Program Advisory Committee Memebers

Purpose - to protect the public from persons regulated by the boards who are unable to practice w/ reasonable skill and safety by reason of illness, use of alcohol, drugs, chemicals, or any other materials, or as a result of any mental, physical, or psychological condition Advisory Committee Members: - 1 member appointed by each of the following: the Minnesota Academy of Physician Assistants, the Minnesota Dental Association, the Minnesota Chiropractic Association, the Minnesota Licensed Practical Nurse Association, the Minnesota Medical Association, the Minnesota Nurses Association, and the Minnesota Podiatric Medicine Association - 1 member appointed by each of the professional associations of the other professions regulated by a participating board not listed above - 2 public members Members of the advisory committee shall be appointed x 2 yrs and members may be reappointed.

When do preceptor registrations expire? What must applicants demonstrate in order for the board to renew their preceptor registration?

QOY on the anniversary of its issuance Applicants must show that: - They are participating in the Experiential Education Program of the U of M College of Pharmacy as an approved preceptor OR - Have completed at least 4,000 hours of practice as a licensed pharmacist, w/ at least 2,000 hours of that practice occurring within the state of MN - They are currently in practice at least 20 hrs/wk as a pharmacist - They have a hx of exemplary practice with respect to compliance with state and federal laws - They will provide time on a regular basis, at least 3x/mo, for the purpose of helping their interns meet the competencies of the internship requirement - For renewal of a registration only, that they have participated in an instructional program specifically for preceptors, provided by or approved by the board, w/in the previous 24 months

Required documentation and time limits for partial CII fills

Record the following on the back of the Rx drug order, or on another appropriate record uniformly maintained and readily retrievable: - Date of the partial dispensing - Qty dispensed - Remaining qty authorized to be dispensed - Unique identifier of the dispensing pharmacist - Whether the pt is "terminally ill" or an "LTCF pt" If requested by pt or prescriber, all partial fills must be completed w/in 30 days If LTCF or terminally ill pt, all partial fills must be completed w/in 60 days If pharmacy does not have enough medication in stock to fill entire Rx, remaining qty must be supplied w/in 72 hrs or a new Rx is needed - Must notate qty dispensed upon initial dispensing

For an individual, if a name change only is requested, the regulated individual must _____.

Request a revised license or registration If an address change only is requested, no request for a revised license or registration is required.